OVERVIEW

The course Applied Medical Technical Sciences – Biomedical Laboratory 2 aims to provide students with advanced knowledge and skills in the fields of laboratory service organization, clinical trials, and biomedical research. The teaching approach integrates both theoretical and practical aspects, with a multidisciplinary perspective focused on quality, safety, and the ethical standards of the healthcare profession.

Through lectures, case study analysis, the use of organizational tools, and discussions on current topics in clinical and scientific fields, the course aims to develop students’ critical thinking, prepare them for work in interprofessional teams, and introduce them to the basic principles of designing and managing clinical and epidemiological studies.

The overall objective is to train professionals capable of actively contributing to innovation and continuous improvement in clinical, diagnostic, and translational research laboratories, always in compliance with ethical values and current regulations.

AIMS AND CONTENT

LEARNING OUTCOMES

Organizational models for diagnostic and translational research laboratories

AIMS AND LEARNING OUTCOMES

Understand organizational models for diagnostic and translational research laboratories.

· Apply tools for organizational analysis, monitoring, non-conformity management, and continuous improvement.

·  Understand the phases, regulations, and ethical principles of clinical trials and pharmaceutical development.

·  Classify epidemiological studies and analyze ethical aspects of clinical trials.

·  Advanced cytometry technologies for clinical analysis.

·  Study of omics in the medical field.

·  Introduction to Translational Medicine.

·  In-depth study of immunological diseases.

PREREQUISITES

Students are required to have met the prerequisites established by the Academic Regulations and outlined in the Manifesto degli studi.

SYLLABUS/CONTENT

Clinical Trials: Planning and Regulations

• Phases of clinical research trials: criteria of efficacy, quality, and safety.
• Fundamental principles: autonomy, beneficence, justice, and bioethics.
• Patients’ Bill of Rights; Ethics Committee; Informed consent.
• Requirements for proper clinical trials: relevant regulations; drug development process and its phases.
• Classification of epidemiological studies: observational vs. experimental; ethical issues; general structure of a clinical trial.
• Interpretation of clinical studies:
  • Reliability analysis: internal validity, endpoints, systematic errors, confidence intervals.
  • Clinical relevance analysis: external validity, clinical benefit, therapeutic efficacy.

Omics, Translational Medicine, and Immunological Diseases

• Clinical applications of omics sciences (genomics, proteomics, etc.).
• Introduction to Translational Medicine.
• Study of immune-mediated diseases: connective tissue disorders, ANA, lupus.

Laboratory Medicine as a Clinical Science

• Understanding the role of Laboratory Medicine as a clinical discipline providing essential information in the diagnostic and therapeutic process.
• Overview of the types and functions of different clinical laboratories.

Immunometric Techniques and Biomarkers

• Knowledge of main immunometric techniques for detecting antigens or antibodies: from non-tracer to tracer-based methods.
• Comparison between competitive and non-competitive assays.
• Analytical issues in immunoassays.
• Definition and clinical use of biomarkers.

Immune Response and Laboratory Evaluation

• Understanding of humoral and cell-mediated immune responses.
• Role of the clinical laboratory in evaluating immunopathological processes.

Tumor Immunology and Immunotherapy

• Key concepts in tumor immunology.
• Role of oncological immunotherapy as a new frontier in cancer treatment.

Plasma Proteins and Clinical Significance

• Types and roles of plasma proteins as indicators of organ function.
• Understanding how protein alterations reveal diseases and help monitor their progression.

TEACHERS AND EXAM BOARD

EXAMS

EXAM DESCRIPTION

The exam will include both oral and written components.

During the examination, the regulations established by the University for the evaluation of students with Specific Learning Disorders (SLD) or other special educational needs will be strictly followed.
These may include, for example:Extended time for written exams;The use of concept maps, which must be submitted for approval to the instructors at least one week prior to the exam date.

ASSESSMENT METHODS

Oral exam

Students with documented Specific Learning Disorders (SLD) or special educational needs must contact the Instructor(s) and the designated SLD Representative within the Department prior to the start of classes, in order to agree on specific teaching arrangements and ensure the proper achievement of course objectives and learning outcomes.